Path 2

Path 2

Trust Me, Baby

September 6, 2005

American women have waited nearly two years for an FDA decision on this drug.photo: Courtesy of Duramed Pharmaceuticals, Inc.

Just two months ago, George Bush’s administration offered Hillary Clinton a deal. If the New York junior senator quit blocking the president’s nominee to head the U.S. Food and Drug Administration, she’d get something in return—a decision on over-the-counter sales of the morning-after pill. The status of the drug, a booster dose of the common birth control pill approved by an FDA advisory panel and the staff itself, has been under consideration for nearly two years.

The senator got all the necessary assurances. Health and Human Services secretary Michael Leavitt promised in a July 13 letter that the FDA, under his oversight, “will act on this application by September 1.” And Senator Michael Enzi, the Republican chair of the committee handling the nomination, on which Clinton sits, pledged to hold a hearing if the promise wasn’t kept. And so Clinton, along with her colleague Patty Murray of Washington, got out of the way. Five days later, the Senate confirmed the new FDA commissioner, Lester Crawford.

Then came August 26, when Crawford announced his agency was taking “action” on the morning-after pill, or Plan B. The FDA did not do what Clinton had anticipated—that is, unveil a ruling on whether to make Plan B available without a prescription. Instead, it indefinitely postponed any ruling. While Crawford admitted that Plan B is safe, he said the age restrictions on teenage girls’ access to it—age restrictions the agency had requested to begin with—have raised legal issues that need examining in a process that could take months, or longer.

Clinton was outraged. That day, she and Senator Murray accused Crawford of choosing politics over science, and of acting in bad faith.

“Secretary Leavitt and the FDA not only broke their promise to Congress, they broke their promise to the American people,” the senators said in a joint statement. “It is a breach of faith to have this administration give us their word that a decision would be made, and have that promise violated.”

In retrospect, Clinton’s aides say, maybe the senator was naïve to take the word of the Bush administration. But who could have imagined the administration would outright snooker two senators? Explains one staffer, “It was everyone’s understanding that they weren’t messing with us.”

The latest development in the Plan B battle reveals more than just the administration’s dishonesty, though. It shows how much the Bush White House remains in the clutches of the right’s most extreme elements. Many conservatives actually support the idea of putting Plan B on drugstore shelves, says Ann Stone of the Virginia-based Republicans for Choice, who counts herself as one. “Clearly,” she adds, “the FDA is pandering to very vocal, extreme right-wing groups.”

With this latest delay, say supporters of Plan B, the FDA has put politics, once again, over science. And because Plan B represents a last chance to deter unwanted pregnancy, they argue, it has put politics over abortion prevention—despite President Bush’s claims to respect the “culture of life.”

“If the pro-lifers are really pro-life, they should be pro–Plan B,” Stone says. “But they are hypocrites for setting up a situation that will result in more abortion, not less.”

Plan B seems like an obvious place to find common ground on abortion, as Clinton famously urged both sides to do in a speech last January. At least, her aides say, the senator thought it was. The drug, after all, is contraception, meant to prevent unintended pregnancies. If it becomes more widely available, then the country could make a real dent in the annual rate of abortions.

Princeton University professor James Trussell, who teaches economics and public affairs, sat on the FDA advisory panel that approved over-the-counter sales of Plan B back in December 2003 (see “Hillary’s Plan B,” July 13–19, 2005). He has analyzed statistics and surveys on women’s health, sexual activity, and contraceptive use, and has estimated that, if Plan B were widely available here, it could reduce the annual number of unintended pregnancies by half. By extension, that means the annual figure of 1.3 million abortions could drop to 650,000.

“We could expect a really powerful impact,” he says.

That benefit has been lost as the Plan B battle has played out. Opponents describe the pill as tantamount to an abortion—it is not, according to medical definitions—and they complain it will encourage promiscuity among young girls. The most outspoken critic, the right-wing Concerned Women for America, has fired off a dizzying array of objections. The group insists it is worried about the long-term safety of the pill, no matter what scientists say. In the 33 countries where Plan B is available without a prescription, CWA argues, a handful of studies have shown a rise in sexually transmitted infections. It has even equated the drug to “a pedophile’s best friend,” imagining that a child rapist could slip the pill to a girl to “hide” his crime.

That such extreme views have gained traction with the FDA has frustrated Plan B proponents. Asked how abortion politics has colored the debate, for instance, Trussell has a hard time hiding his disdain. “There are no two sides to this issue,” he says. “What those people are spouting is their political ideology, not science. It’s just nonsense.”

Kirsten Moore, of Reproductive Health Technologies Project, puts it this way: “These are not credible opponents, and the fact that the agenda is marching to their tune hurts.”

It hurts enough for a top FDA official, Susan Wood, a biologist and former head of the agency’s women’s health office, to up and quit. On August 31, Wood sent out an e-mail message to agency staff announcing her resignation effective immediately. “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” she wrote. Trussell says many of his scientist contacts inside the agency feel “extreme discontent” these days. He adds, “It’s a very discouraging place to work when the scientific evidence can get overruled by the political masters.”

The day Wood resigned, Senators Clinton and Murray fired off a statement of their own, expressing their dismay. They responded to the news with a letter to Senator Enzi, urging him to keep his promise to hold a health committee hearing. Now the time has come, as they put it, “to allow science, not politics, to guide” the FDA.

Interestingly, opponents were also presenting their cause as a victim of politics. Concerned Women for America released a statement hailing Wood’s exit, declaring things safer now that there’s “one less political activist at the FDA who puts radical feminist ideology above women’s health.”

Evidently, as even Clinton staffers agree, the Plan B battle has no middle ground. “It feels like opponents just keep moving the goalposts,” one aide confides.

Much of the senator’s liberal base would have predicted as much. When she gave her speech calling for common ground on abortion, the sounds of ridicule and disgust could be heard all over the liberal blogosphere. People thought the senator was trying to make a deal with folks who aren’t going to give an inch. They saw it as a sign of appeasement, a willingness to let the hard-right frame the debate.

But, as Steve Gilliard, who writes the liberal News Blog, in Manhattan, and who opened his post about Clinton’s speech by asking, “Is she delusional?” points out, “Every time you try to find common ground with these folks, they raise the stakes.” First they’re against abortion. Then they’re against contraception. Then they’re against pharmacists filling birth-control prescriptions.”

If the Plan B battle reveals anything, it’s that the opponents’ real agenda is not to prevent unintended pregnancy and abortion. If that were so, they would be for all forms of contraception. They’d be for better sex education. They’d be for more family-planning counseling. “The problem is the right doesn’t want greater access to birth control,” Gilliard says, “and their opposition to Plan B proves it.”

For now, though, all proponents can do is try to keep fighting. On September 2, Senators Clinton and Murray, along with 11 other senators, reminded another government body, the Government Accountability Office, of their request, last year, for it to investigate whether the FDA’s handling of Plan B was based on politics rather than science. Marcia Cross, of the GAO health-care team, says the investigation is not yet complete. But she tells the Voice that researchers will compare the FDA’s ongoing delays of Plan B to other of its over-the-counter decisions, as well as to decisions on a range of contraceptive products.

Expect Clinton to make more moves soon, her staff says. “Everyone here is hoping there is a resolution as she and Senator Murray have defined it,” her spokesperson Philippe Reines explains, by which he means a yes or no decision on Plan B. “This is a step back, but it’s not over yet. The senator is really worked up about it.”